This invention relates to a device for the maintenance of a percutaneous sinus tract made for the purposes of introduction or removal of fluids or material by catheterization.
Chronic intermittent sinus tract access is required for a variety of medical procedures such as, for example, catheterization for the purposes of chronic peritoneal dialysis.
The standard procedure for chronic peritoneal dialysis is effectuated by implantation of a silastic catheter surgically, under general or regional anesthesia, or with a trocar or a stylet device.
One trocar device for such purposes is more fully described in U.S. Pat. Nos. 3,064,653 and 3,149,186. Such device is commonly known as a "Trocath Peritoneal Dialysis Catheter" (trocar), and is comprised of a catheter, stylet (trocar) and device for attachment to dialysis equipment.
The trocath is comprised of a metal stylet with handle (trocar) and a catheter sleeved around the stylet. It is also usually provided with a connecting device for attachment to the catheter after insertion.
The trocath catheter and stylet are introduced through an enlarged puncture site in the epidermis and then carefully pushed through the peritoneal cavity resulting in the formation of a sinus tract enclosing the catheter and stylet. The stylet is then removed and the catheter is introduced further into the peritoneal cavity to rest in the left or right pelvic gutter. Thereafter a dialysis apparatus is connected to the connecting means attached to the catheter. Dialysis treatment is then effectuated.
After any catheter treatment has been completed, it is usually desirable to remove the catheter between procedures such as in the case of chronic peritoneal dialysis. However, this sometimes results in the undesirable loss of the sinus tract which has been formed by surgery or a trocar stylet thereby making it necessary to form a new sinus tract with the aid of a physician before the next treatment. Also, it is most desirable to avoid repetition of the sinus tract formation procedure for subsequent treatments.
Previously maintaining the integrity of the sinus tract for intermittent dialysis procedures has been attempted by the use of a device described in U.S. Pat. No. 3,505,988 commonly known as "Deane's Peritoneal Prosthesis". Deane's prosthesis is comprised of a pliable plastic rod with a terminal disc. The Deane's prosthesis is introduced into the empty sinus tract subsequent to catheter removal and remains in place with the plastic rod in the sinus tract and the terminal disc resting on the epidermis. It is then normally secured with adhesive tape. The Deane's prosthesis is then left in place until just prior to subsequent catheter reintroduction.
However, when a solid one piece peritoneal prosthesis, such as the Deane's prosthesis, is utilized, it has been found that prior to the insertion of a peritoneal catheter after removal of the prosthesis, the sinus tract to the peritoneum is lost approximately 15% of the time and reintroduction of a new peritoneal trocar or further surgery is required to establish a new sinus tract to the peritoneum, again requiring the attendance of a skilled physician and carrying its associated morbidity. Additionally reintroduction of a catheter when only using Deane's prosthesis to maintain sinus tract integrity requires the use of a reluctantly stiff catheter precluding the use of more flexible catheters.
An object of this invention is to provide a prosthesis which will easily maintain a sinus tract between catheterizations.
Another object of this invention is to provide a prosthesis which, while maintaining sinus tract integrity, also forms a guide for reintroduction of a catheter.
Another object of this invention is to provide a prosthesis which provides an easy means of "sealing" the sinus tract between catheterizations, while maintaining the integrity of the sinus tract, to reduce the risk of infection or the undesirable introduction or loss of material through the sinus tract.
Another object of this invention is to provide a prosthesis which maintains the integrity of the sinus tract and allows for the introduction of a catheter through the sinus tract to the peritoneum or other location without the necessity of the attendance of a skilled physician.
Another object of this invention is to provide a prosthesis for sinus tract maintenance which is easy to use and will be subject to widespread use.
Other objects, features and advantages of the invention will become more apparent from the following description.